Bangavax gets DGDA nod for human trial

After a long wait and a successful trial on animals, Bangavax, developed by Globe Biotech, has been approved for human trial.
On Sunday a letter signed by the Director General of the Directorate General of Drug Administration Maj Gen Mohammad Yusuf conveyed the approval of the vaccine developed by Globe Biotech.
Mohammad Mohiuddin, the Senior Manager of Quality and Regulatory Department of Globe Biotech Ltd confirmed the matter.
He said, "Today we have got the permission for human trial. Details will be given later."
Bangvax proved to be safe and effective in pre-clinical trials on rabbits, rats and monkeys after analyzing its data, Bangladesh Medical Research Council (BMRC) gave ethical approval for experimental application in humans on November 23 in 2021.
According to Globe Biotech, the trial will be conducted on 60 individuals at the Bangabandhu Sheikh Mujib Medical University (BSMMU). The Bangvax vaccine is made of natural pure mRNA (messenger ribonucleic acid),
    so it has the highest chance of being safe and effective. Bangvax vaccine is one dose. If it is approved, demand will be created abroad.
Globe Biotech Ltd announced the discovery of coronavirus vaccine for the first time in the country on July 2 in 2020. Three and a half months later, on October 15, the World Health Organization (WHO) included Globe Biotech's three vaccines in the candidate list. Globe Biotech is the only company in the world to have a maximum of three vaccines on the candidate list.
On January 17 last year, the protocol was submitted to the BMRC for the first and second phase of the principle trial of Bangavax. The revised protocol was then submitted on February 17 as per the demand of BMRC.
Later on June 22 in 2021, the BMRC allowed human testing of Bangvax, although it was stipulated that it should be tested on monkeys or chimpanzees first. On August 1, the manufacturer company started the trial on monkeys which ended on October 21.
After that, Globe Biotech applied to the DGDA on November 25 of last year for the final approval of the vaccine's application in human trial.